← Back to manufacturers

Is this your brand? Sign in to claim ownership.

Sign in to claim this brand

Route 92 Medical, Inc.

United States·US-MF-000007441

Last updated September 18, 2026

About

Route 92 Medical is committed to improving outcomes for neurovascular patients through revolutionary procedural change.

From the manufacturer's own website. Source

Information

Country
United States
Address
155 Bovet Rd, Suite 100, San Mateo, United States
Website
www.r92m.com
LinkedIn
linkedin.com/company/route-92-medical
Facebook
—
Email
[email protected]
Phone
—
PRRC Contact
Matthew Fortson
EUDAMED SRN
US-MF-000007441
FDA FEI Number
—
DUNS Number
—

Catalogue (58)

Page 1 of 2
DeviceModel / ReferenceRegistriesClassStatus
Tenzing 7 Delivery Catheter, Single Pack Gen 1
FDA UDI
Class IIActive
FreeClimb 88 catheter, 125cm Gen 1
FDA UDI
Class IIActive
Tenzing 8 Delivery Catheter Gen 1
FDA UDI
Class IIActive
8F Base Camp Sheath System Gen 1.5
FDA UDI
Class IIActive
Tenzing 7 Delivery Catheter Gen 1
FDA UDI
Class IIUnknown
088 x 132 cm Full Length Catheter Gen 1
FDA UDI
Class IIUnknown
FreeClimb 54 x 125 cm Access System Gen 1
FDA UDI
Class IIUnknown
088 x 125 cm Full Length Catheter Gen 1
FDA UDI
Class IIUnknown
Tenzing 7 Delivery Catheter, 2-pack Gen 1
FDA UDI
Class IIActive
FreeClimb 70 reperfusion catheter, 132cm Gen 1
FDA UDI
Class IIActive
FreeClimb 54 reperfusion catheter, 148cm Gen 1
FDA UDI
Class IIActive
HiPoint 88 reperfusion catheter with Tenzing 8 Gen 1
FDA UDI
Class IIActive
Tenzing 7 Delivery Catheter Gen 1
FDA UDI
Class IIActive
Tenzing 5 delivery catheter Gen 1
FDA UDI
Class IIActive
FreeClimb 70 reperfusion catheter, 132cm with Tenzing 7 Gen 1
FDA UDI
Class IIActive
FreeClimb 54 reperfusion catheter, 125cm with Tenzing 5 Gen 1
FDA UDI
Class IIActive
HiPoint 70 reperfusion catheter with Tenzing 7 Gen 1
FDA UDI
Class IIActive
FreeClimb 54 x 125 cm Catheter Gen 1
FDA UDI
Class IIUnknown
8F Base Camp system 2.0 90cm Gen 2.0
FDA UDI
Class IIActive
088 Access System Gen 1
FDA UDI
Class IIActive
070 Catheter Gen 1
FDA UDI
Class IIActive
FreeClimb 88 catheter, 132cm with Tenzing 8 Gen 1
FDA UDI
Class IIActive
070 Access System Gen 1
FDA UDI
Class IIActive
088 x 132 cm Full Length Access System Gen 1
FDA UDI
Class IIUnknown
FreeClimb 54 reperfusion catheter, 148cm with Tenzing 5 Gen 1
FDA UDI
Class IIActive
FreeClimb 88 catheter, 132cm Gen 1
FDA UDI
Class IIActive
8F Base Camp system 2.0 90cm Gen 2.0
FDA UDI
Class IIActive
FreeClimb 54 reperfusion catheter, 125cm Gen 1
FDA UDI
Class IIActive
FreeClimb 54 x 148 cm Catheter Gen 1
FDA UDI
Class IIUnknown
8F Base Camp Sheath System Gen 1.5
FDA UDI
Class IIActive
088 x 125 cm Full Length Access System Gen 1
FDA UDI
Class IIUnknown
FreeClimb 88 catheter, 125cm with Tenzing 8 Gen 1
FDA UDI
Class IIActive
8F Base Camp system 2.0 80cm Gen 2.0
FDA UDI
Class IIActive
Tenzing 7 Delivery Catheter Gen 1
FDA UDI
Class IIActive
088 Catheter Gen 1
FDA UDI
Class IIActive
FreeClimb 54 x 148 cm Access System Gen 1
FDA UDI
Class IIUnknown
FreeClimb 88 reperfusion catheter (x132cm) with Tenzing 8 7001-88-132R-EU
EUDAMED
Class IIIActive
Route 92 Medical Delivery Catheter K190431
FDA 510(k)
Class IIActive
Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set K233329
FDA 510(k)
Class IIActive
Route 92 Medical 070 Access System K203043
FDA 510(k)
Class IIActive
Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set K223530
FDA 510(k)
Class IIActive
8F Modified Sheath System K240529
FDA 510(k)
Class IIActive
Route 92 Medical Access System K180201
FDA 510(k)
Class IIActive
Route 92 Medical Full Length 088 Access System K210635
FDA 510(k)
Class IIActive
Route 92 Medical 088 Access System K201518
FDA 510(k)
Class IIActive
Route 92 Medical Full Length 070 Access System K222743
FDA 510(k)
Class IIActive
Route 92 Medical Full Length 054 Access System K231583
FDA 510(k)
Class IIActive
Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set K243601
FDA 510(k)
Class IIActive
Route 92 Medical Delivery Catheter K182512
FDA 510(k)
Class IIActive
Route 92 Medical 088 Access System, 110 cm K200121
FDA 510(k)
Class IIActive

Related Companies

Authorised Representatives

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.